About This Role
This role supports Cencora's patient and provider support and pharma commercialization services in Canada, marketed through its Innomar Strategies business. The Drug Safety Associate is responsible for managing clinical information and adverse event data in compliance with regulations and client needs.
Responsibilities
- Receive, scan, and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
- Work directly with internal and external clients to request additional information or clarification as necessary
- Review source data documents (includes visit report/PIR review) and triage adverse event information and product quality complaints as per client needs
- Data entry and submission of adverse event information and product quality complaints into program-specific databases
- Sort and file incoming documents
- Perform quality checks on adverse event reports as directed by the work instructions
- Assist with and/or perform source data verification checks
- Screen medical and scientific literature for safety information
- Prepare Reconciliation (weekly, monthly, etc.) Reports
- Perform transcription, translations, and redaction activities
- Prepare and conduct solicited follow-up letters and data clarifications
- Assist and participate in the non-conformance/CAPA process
- Perform other duties and tasks as required from time to time
Requirements
- Minimum college-level education required
- Diploma or degree with a concentration in Life Sciences is a strong asset
- 1-3 years of experience in Medical Information, Clinical Research, or Drug Safety, or equivalent and related experience in pharmacy or pharmaceutical fields
- Knowledge of the Pharmacovigilance industry, including up-to-date knowledge of pharmacovigilance guidelines of Health Canada, US FDA, EMEA, and ICH
- Adaptability to change and to learn new skills as required
- Experience in the medical and/or pharmaceutical field(s), medical terminology is an asset
- Bilingual, English/French is an asset
- Strong analytical skills
- Ability to communicate effectively both orally and in writing
- Effective interpersonal skills
- Effective organizational skills; ability to multitask
- Superior, proven attention to detail
- Ability to consistently meet deadlines
- Excellent problem-solving skills; ability to communicate and/or resolve issues effectively and efficiently
- Computer skills (including knowledge of Microsoft Word, Excel, PowerPoint, and other Office Programs)
- Good internet required for remote work
Benefits
- Comprehensive, diverse benefits programs designed to meet the varied needs of all associates
- Many benefits are company-paid, while others are offered through associate contributions
About the Company
Cencora is committed to making a difference in patients' lives, fostering an innovative and collaborative culture focused on patient care. The organization is united by its responsibility to work for healthier lives.
